Thursday January 24, 7:30 am Eastern Time
Press Release
SOURCE: Genaissance Pharmaceuticals, Inc.
Genaissance Pharmaceuticals Announces First Drug Development Candidates
Company Leverages Technology Investment Into New Products That Combine Pharmaceuticals and Proprietary Genetic Markers
NEW HAVEN, Conn., Jan. 24 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. (Nasdaq: GNSC - news) today outlined its strategy for applying its proprietary HAP(TM) Technology to develop a product pipeline of ``best in class'' personalized medicines at the 4th Annual Personalized Medicine: Opportunities and Challenges for Commercialization conference in San Francisco, CA. Genaissance products, known as HAP(TM) Drugs, combine pharmaceutical compounds with genetic markers that define the patient population which responds best to the medication and has a superior safety profile. The first two product candidates are HAP(TM)-Clozapine for schizophrenia and HAP(TM)-Statin for cholesterol management. These internal HAP(TM) Drug development programs will complement existing business strategies focused on establishing technology and drug-specific partnerships with pharmaceutical and biotechnology companies.
``We are translating the advances made with our HAP(TM) Technology and clinical research programs into the development of pharmaceutical products,'' said Gualberto Ruano, M.D., Ph.D., CEO of Genaissance. ``Genaissance is now one of only a few companies with a product pipeline utilizing genomics technologies and is at the forefront of leveraging human gene variation data to develop new drugs.''
HAP(TM) Drugs represent a significant business opportunity for Genaissance. The goal is to utilize the Company's HAP(TM) Technology to create superior products from drugs that were previously undifferentiated, had an unpredictable safety profile, had a narrow therapeutic window or whose patent had expired. The Company's drug development process starts with the identification of pipeline or off-patent compounds that meet the above criteria. The Company will then conduct Phase II-sized clinical association studies to identify the genetic marker(s) that are predictive of drug safety and efficacy. Compared to traditional drug development, the HAP(TM) Drug development strategy is a rapid, lower-risk process to select compounds for entry into late phase clinical trials. The Company may formulate certain drug candidates to further enhance their performance. Genaissance also has an active joint venture and in-licensing effort to identify pipeline products that may not be realizing their full potential.
``Genaissance is planning to use its technology platform to leapfrog some of the costly and time-consuming drug discovery and development steps,'' said Kevin Rakin, Genaissance President and CFO. ``We believe that we have the ability to create substantial shareholder value by developing a series of proprietary, ''best in class`` products.''
HAP(TM)-Clozapine
Although highly effective, clozapine is restricted by its label to third-line therapy of schizophrenia at least in part because of the risk of agranulocytosis, a potentially life-threatening depletion of white blood cells. The need for repeated blood tests to monitor for the development of agranulocytosis results in poor patient compliance, restricts market share and limits sales to approximately $350 million in the U.S. Minimizing or eliminating the need for frequent blood monitoring by reducing the risk of agranulocytosis would enable many more patients to benefit from using clozapine. It is expected that development of HAP(TM)-Clozapine will be initiated in the first quarter of 2002 with a study designed to identify the genetic marker(s) associated with agranulocytosis. Approximately 200 patient samples will be collected and analyzed over a nine month period. The funding of the study was previously included in the Company's financial guidance provided for this year. If additional product milestones are met, it is expected that the development of HAP(TM)-Clozapine could be completed in 2005. The antipsychotic market in the U.S. is projected to reach $8 billion by 2005.
HAP(TM)-Statin
The planned HAP(TM)-Statin will have a target profile of superior performance in changing the levels of biochemical markers related to the prevention, development and progression of atherosclerotic disease. Final product selection and a development timeline will be finalized once the study data from the STRENGTH I and II clinical trials are fully analyzed in the first half of 2002. If additional product milestones are met, it is expected that the development of HAP(TM)-Statin could be completed in 2005. The U.S. statin market is expected to grow to $17 billion in 2005.
About Genaissance
Genaissance Pharmaceuticals, Inc. is the world leader in the discovery and use of human gene variation for the development of personalized medicines. The Company has identified candidates for development in its own pipeline of products -- HAP(TM)-Clozapine and HAP(TM)-Statin -- utilizing its proprietary genetic markers. The Company also markets its technology and clinical development skills to the pharmaceutical industry as a complete solution for improving the development, marketing and prescribing of drugs. Genaissance has agreements with three of the top ten pharmaceutical companies: AstraZeneca, Johnson & Johnson and Pfizer. Genaissance is located in Science Park in New Haven, Connecticut. Please visit genaissance.com for additional information.
This press release contains forward-looking statements, including statements about the ability of Genaissance to apply its technologies to the development, marketing and prescribing of drugs, and the expected release of clinical trials data. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performance to differ materially from those referred to in such statements, including, but not limited to, the development of new products, the extent to which genetic markers (haplotypes) are predictive of drug efficacy and safety, the adoption of our technologies by the pharmaceutical industry, the timing and success of clinical trials, competition from pharmaceutical, biotechnology and diagnostics companies, the strength of our intellectual property rights and those risks identified in our Registration Statement on Form S-3 filed with the Securities and Exchange Commission on October 18, 2001 and our Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 2, 2001. The forward-looking statements contained herein represent the judgment of Genaissance as of the date of this release. Genaissance disclaims any obligation to update any forward-looking statement.
Contact: Paul Oestreicher, Ph.D. (media) Rhonda Chiger (investors)
203-786-3490 917-322-2569
p.oestreicher@genaissance.com rchiger@RxIR.com
or
Genevieve Faith (media)
203-786-3660
g.faith@genaissance.com
SOURCE: Genaissance Pharmaceuticals, Inc. |
